Kornimate/medical-research-clean huggingface dataset:
afatinib combined with chemotherapy as conversion therapy in unresectable egfr sensitive mutation-positive stage iii nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a phase ii, single-arm study to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable egfr sensitive mutation-positive stage iii non-small cell lung cancer.

this single-arm, open-label, prospective phase ii clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable egfr sensitive mutation-positive stage iii non-small cell lung cancer. the primary endpoint was the rate of nsclc converting to resectable tumors. the secondary endpoints included r0 resection rate, major pathological response (mpr) rate, pathological complete response (pcr) rate, tumor downstaging rate, objective response rate (orr), disease control rate (dcr), 1-year event-free survival (efs) rate, efs and overall survival (os).

Eligibility criteria:
inclusion criteria: * pathologically or cytologically confirmed diagnosis of unresectable stage iii non-small cell lung cancer as judged by the investigator. * tissue or blood samples tested and confirmed to be positive for egfr sensitive mutation * ecog performance status of 0-1 * at least one measurable lesion according to recist 1.1 * adequate organ and marrow function exclusion criteria: * histologically or cytologically confirmed combined sclc and nsclc, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma * the presence of malignant pleural effusion * prior systemic anti-cancer therapy for non-small cell lung cancer * prior local radiotherapy for nsclc * patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ grade 2 ctcae) according to the investigator's assessment

Keywords: conversion therapy afatinib
degenerative cervical myelopathy repository

Conditions: Cervical Myelopathy

Summary: to create a research repository of patients with known degenerative cervical myelopathy (dcm) and a control cohort of subjects who have non-myelopathic spinal disease. this repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with dcm. in addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of dcm.


Eligibility criteria:
inclusion criteria: * diagnosis of degenerative cervical myelopathy * diagnosis of cervical degenerative disease without myelopathy exclusion criteria: * none outside or diagnostic requirements and age limits.
the balance study: a study in spain to find out whether a patient support program helps people with pulmonary fibrosis who take nintedanib

Conditions: Pulmonary Fibrosis

Summary: the aim of this study is to describe patients' satisfaction with patient support program (balance program), quality of life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.


Eligibility criteria:
inclusion criteria * adults (≥18 years old at baseline). * patients included in the patient support program (psp) balance program. * ability to read and speak spanish correctly according to the investigator criteria. * agree to participate and signing informed consent at baseline. exclusion criteria - suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.
study evaluating the safety and efficacy of jwcar029 in adult subjects with relapsed and refractory b-cell non-hodgkin lymphoma

Conditions: Non Hodgkin Lymphoma

Summary: this is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous cd19-targeted chimeric antigen receptor (cd19 car) t cells in adult patients with relapsed and refractory b-cell non-hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria to be enrolled in this study: 1. age ≥ 18 years at the time of consent 2. signed written informed consent obtained prior to any study procedures 3. relapsed or refractory b-cell nhl. 4. pet-positive disease by lugano classification 5. archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. if a subject has never had a complete response, a sample from the most recent biopsy is acceptable. 6. eastern cooperative oncology group (ecog) performance status of 0 or 1. 7. adequate bone marrow, renal, hepatic, pulmonary and cardiac function 8. adequate vascular access for leukapheresis procedure 9. subjects who have received previous cd19-targeted therapy must have cd19-positive lymphoma confirmed on a biopsy since completing the prior cd19-targeted therapy 10. subjects must agree to use appropriate contraception. exclusion criteria: * subjects who meet any of the following criteria will be excluded from participation in this study: 1. subjects with central nervous system (cns)-only involvement by malignancy (note: subjects with secondary cns involvement are allowed on study) 2. history of another primary malignancy that has not been in remission for at least 2 years. 3. treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis 4. active hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) infection at the time of screening 5. subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or jwcar029 administration 6. presence of acute or chronic graft-versus-host disease (gvhd) 7. history of cardiovascular disease 8. history or presence of clinically relevant cns pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 9. pregnant or nursing women. 10. prior car t-cell or other genetically-modified t-cell therapy, with the exception of prior jwcar029 treatment in this protocol for subjects receiving retreatment

Keywords: non hodgkin lymphoma cd19-targeted chimeric antigen receptor jwcar029
a study to describe the safety of a vaccine (called 13vpnc) in healthy people 18 to 49 years of age in india

Conditions: Pneumococcal Disease

Summary: * the purpose of this study is to describe the safety of the study vaccine (called 13vpnc) in people who are 18-49 years of age in india. * this study is seeking participants who are generally healthy adults ≥18 and \<50 years of age, with no prior history of pneumococcal vaccination. * participants will take part in the study for approximately one month which includes two visits to the study clinic. * participants will receive a single dose of study vaccine (13vpnc) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.


Eligibility criteria:
inclusion criteria: * generally healthy participants between the ages of ≥18 and \<50 years at the time of consent. * participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. exclusion criteria: * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vpnc, or to any other diphtheria toxoid-containing vaccine. * congenital, functional, or surgical asplenia. * other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
porcine xenograft or microbial cellulose in the treatment of partial thickness burns

Conditions: Burns; Burn Scar; Burn Second Degree

Summary: the purpose of this study was to compare two wound dressing products for partial thickness burns in adults.

after being informed about the study, all patients that had given written informed consent underwent screening. if eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. dressing were applied within 72 hours after burn injury. evaluation was done in an open manner due to the specific characteristics of the dressings. study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.

Eligibility criteria:
inclusion criteria: * study participants admitted within 72 hours of injury * partial-thickness burns requiring a temporary skin cover * written informed consent exclusion criteria: * severe coexisting cutaneous trauma * chronic or current skin disease, * severe cognitive dysfunction or psychiatric disorder * pregnant or breast feeding women were excluded.
learning curve of digital rectal examination for prostate cancer among internship

Conditions: Prostatic Neoplasms; Digital Rectal Examination; Benign Prostatic Hyperplasia

Summary: the investigators conduct this prospective study to investigate the learning curve of digital rectal examination (dre) for prostate cancer among internship. the investigators want to know how many dre are usually needed for internship to be performed in urological practice to obtain a stable dre accuracy.

digital rectal examination (dre) is a basic physical examination in routine practice in urology. the dre is a very important daily practice for screen prostate cancer, and each internship in urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. however, how many dre are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. the investigators thus conduct this prospective trial to investigate the learning curve of dre among internship.

Eligibility criteria:
inclusion criteria: * internship just graduate from the medical school, and agree to attend the study. * internship have less than 5 dres of prostate cancer. * patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: psa\>4ng/ml, fpsa/tpsa\<0.16, with suspected palpable nodes in the prostate by dre of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography. exclusion criteria: * internship who are not willing to attend the study. * internship stop doing dre for continuously 3 months after entering the study.

Keywords: prostate cancer; benign prostatic hyperplasia; digital rectal examination; accuracy
influence of intermittent fasting on locally advanced breast cancer patients

Conditions: Locally Advanced Breast Cancer; Intermittent Fasting

Summary: breast cancer is the most common cancer type among women in egypt and world. preclinical studies show fasting reduces growth factors and modulates nutrient sensing systems, protecting normal cells against chemotherapy. however, cancer cells are not protected due to differential stress resistance (dsr), making them more vulnerable to chemotherapeutics. this study aims to evaluate intermittent fasting impact on neoadjuvant chemotherapy in breast cancer patients.


Eligibility criteria:
inclusion criteria: * female patients with stage ii or iii (ct1cn+ or ≥t2 any cn, cm0) breast cancer. - planned to receive standard neoadjuvant chemotherapy. * measurable disease (breast and/or lymph nodes). * who performance status 0-2. * being overweight (bmi: 25-29.9 kg/m2) or obese (bmi: ≥30 kg/m2). * adequate bone marrow function : white blood cells (wbcs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * adequate liver function: bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl * adequate renal function: the calculated creatinine clearance should be ≥50 ml/min * patients must be accessible for treatment and follow-up exclusion criteria: * serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * diabetes mellitus. * pregnancy or lactating * any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods. * previous malignancy. * using weight loss medication.

Keywords: locally advanced breast cancer hr positive her2 negative breast cancer intermittent fasting
effects of exercise and education in patients with chronic pain after total knee replacement

Conditions: Arthroplasty, Replacement, Knee; Chronic Pain

Summary: the purpose of the study is to investigate whether a 12-week neuromuscular rehabilitation program (nemex-tjr) combined with pain neuroscience education (pne) provides greater pain relief, improvement in physical function and quality of life than pne alone in a population of patients with chronic pain after primary total knee arthroplasty. hypothesis: rehabilitation involving neuromuscular training and pne will provide greater pain relief, improved function and improved quality of life compared to pne alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

osteoarthritis is considered the most frequent cause of disability and pain in the elderly population, and the knee joint is one of the joints most commonly affected. end-stage osteoarthritis is often treated with knee replacement, and total knee arthroplasty is considered an effective treatment for pain relief and improved function. however, several studies have reported less favorable outcomes after total knee arthroplasty, and systematic reviews found chronic pain after total knee arthroplasty at 12 months post-operative in 13-17% of the patients and chronic pain rates at 2-7 years post-operative varying between 8-27%. no randomized controlled trials evaluating exercise and pain education treatments to patients with chronic pain after total knee arthroplasty exists, and this highlights the need for evidence-based knowledge of which treatment should be considered for this population.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 19-40 * subjects with primary total knee arthroplasty due to osteoarthritis ≥ 12 months post-operatively * for the index knee, duration of knee pain \> 6 months * for the index knee, the average daily pain score ≥ 4 (moderate-to-severe pain) over the last week prior to visit on a numeric rating scale exclusion criteria: * specific reasons for chronic pain, such as loosening of implant, which requires revision surgery * secondary causes of arthritis to the knee, e.g. rheumatoid arthritis * surgery (including arthroscopy) of the index knee within 3 months prior to visit * injury to the index knee within 12 months prior to visit * recent history of acute pain affecting the lower limb and/or trunk * participation in other pain trials two weeks prior to this study * pregnancy * drug and alcohol abuse * previous neurologic illnesses or primary pain area other than knee, e.g. lower back, upper extremity pain or rheumatoid arthritis * lack of ability to adhere to protocol

Keywords: chronic pain total knee arthroplasty pain neuroscience education neuromuscular exercise (nemex-tjr)
the effects of midazolam on the quality of postoperative recovery

Conditions: Postoperative Period; Anxiety; Fatigue; Depression; Aggression

Summary: the purpose of this study is to determine whether midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.


Eligibility criteria:
inclusion criteria: * all patiënts operated with a laparotomy in the erasmus medical center of rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days exclusion criteria: * pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients

Keywords: quality of recovery
prasugrel or ticagrelor de-escalation in nste-acs

Conditions: Non ST Segment Elevation Acute Coronary Syndrome; Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Unstable Angina

Summary: the proteus study is a randomized, cross-over, open-label, pharmacodynamic trial designed to compare the antiplatelet effect of reduced maintenance doses of prasugrel and ticagrelor in stable patients who recently had non-st-elevation acute coronary syndrome (non-st-elevation myocardial infarction or unstable angina).


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * diagnosis of non-st-segment elevation acute coronary syndrome (non-st-segment elevation myocardial treatment or unstable angina) * male or non-pregnant female, aged 18-75 years old exclusion criteria: * known hypersensitivity to ticagrelor or prasugrel * presence of contraindications for ticagrelor or prasugrel * current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin * history of ischemic stroke or transient ischemic attack * history of intracranial hemorrhage * recent gastrointestinal bleeding (within 30 days) * history of moderate or severe hepatic impairment * history of major surgery or severe trauma (within 3 months) * patient required dialysis * concomitant therapy with strong cyp3a inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong cyp3a inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment * body weight below 60 kg

Keywords: acute coronary syndrome de-escalation prasugrel ticagrelor
longitudinal study of the menopause and fat patterning

Conditions: Cardiovascular Diseases; Menopause; Heart Diseases

Summary: to study the natural history of the accumulation of intra-abdominal fat as women progress through the menopause.

background: menopause alters the risk for a variety of chronic diseases, including cardiovascular disease, which is the number one cause of mortality in older women. while the associations between menopause, increased total and intra-abdominal fat (iaf), and risk for coronary disease are well established, prospective studies describing the accumulation of iaf, the association with risk factors, and potential mechanistic aspects, are still lacking. this study has the potential to provide important information on the trajectory of iaf accumulation across the menopausal transition in minority and non-minority women. design narrative: the prospective study will be conducted on an intact biracial cohort of 868 women (419 african americans; 449 caucasians) who are participating in a larger study (women in the southside health \[wish\] project) of women undergoing the menopausal transition. this is a population-based cohort that was randomly selected from an existing census with a 72 percent participation rate, approximately equal distribution of socioeconomic status within the african american and caucasian subgroups, and a dropout rate of only 1 percent/year. as part of the larger study, this cohort undergoes annual exams in which a variety of cardiovascular, hormonal, and lifestyle factors are tracked. these annual measurements consisting of a large number of relevant covariates, including demographics, anthropometrics, serum lipids, blood pressures, insulin, glucose, hormones, lifestyle, health and psychosocial status will be available from the parent study. for this study, two additional clinical tests will be added to the battery at the fourth or fifth annual exam for the 536 women who are expected to be eligible by virtue of not having had a hysterectomy or begun taking hormone therapy. the two tests will be a computed tomography scan for the assessment of intra-abdominal fat, and a dual energy x-ray absorptiometry (dexa) scan for the assessment of total body fat. these tests will be repeated on an annual basis for the next three years. by the end of the study, it is projected that 462 transitions in menopausal status will have taken place. random effects models will be used to estimate longitudinal changes in level and rate of intra-abdominal fat as one moves from one menopausal status to another.

Eligibility criteria:
women eligible for this ancillary study had no history of diabetes, chronic liver disease or renal disease, no self-reported history of anorexia nervosa, no alcohol or drug abuse, were not currently pregnant or planning to become pregnant, and had not undergone hysterectomy and/or bilateral oophorectomy. equipment limitations precluded participation of women with breast implants, hip replacements, or weighing ≥299 pounds.
nivolumab in combination with ipilimumab (part 1); nivolumab plus ipilimumab in combination with chemotherapy (part 2) as first line therapy in stage iv non-small cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: the purpose of part 1 of this study is to determine the objective response rate (orr) in stage iv nsclc subjects treated with nivolumab in combination with ipilimumab as first line therapy. the purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage iv nsclc.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * diagnosed with stage iv non-small cell lung cancer * diagnosed with recurrent stage iiib non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options. exclusion criteria: * subjects with untreated cns metastases are excluded. * subjects with carcinomatous meningitis * subjects with an active, known or suspected autoimmune disease. * subjects with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment. * women who are pregnant, plan to become pregnant, and/or breastfeed during the study. other protocol defined inclusion/exclusion criteria apply